Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current standard of care at the Thunder Bay Regional Health Sciences Centre is referral for treatment by either needle decompression therapy by a radiologist or shockwave therapy by a physiotherapist. The purpose of this study is to compare the efficacies of these treatment options.
Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current guidelines recommend conservative management initially and failing this, a variety of minimally invasive options exist. These include subacromial steroid injection (SSI), needle decompression (ND), and Shock wave therapy (SWT).
Few trials of these methods exist, but generally a benefit is seen with all minimally invasive methods. Most promising results have occurred with needle decompression and shockwave therapy. To date, no direct trials comparing SWT and ND have been published.
The purpose of this trial is to preliminarily establish the comparative efficacies of NDSSI and SWT using a number of outcome measures. Secondarily, the investigators aim to determine prognostic factors for success of minimally invasive therapies. The results of this study will serve as a foundation for more rigorous trials in this area.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NDSSI | Active Comparator | Participants in this arm of the trial will be referred for Needle decompression with subacromial steroid (Depo medrol) injection (NDSSI) as their treatment for calcific tendinitis |
|
| SWT | Active Comparator | Participants in this arm of the trial will be referred for Shockwave therapy (SWT) using an Ultrasound device, delivered by a physiotherapist, as their treatment for calcific tendinitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle decompression | Procedure | Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Range of Motion | The change in a Participant's Range of Motion as measured by a goniometer (Passive Range of Motion [PROM] and Assistive Range of Motion [AROM]) from baseline to 3 months and 1 year. | Baseline, 3 months, 1 year |
| Change of Western Ontario Rotator Cuff (WORC) score | Change in a participant's WORC scores from baseline to 3 months and 1 year. WORC is a condition-specific outcome tool for people with rotator cuff disorder. A total score for each domain is calculated (Physical Symptoms/600; Sports and Recreation/400; Work/400 and Lifestyle/400;Emotions/400) and the total score for the domains is summed for an aggregate score out of 2100. | Baseline, 3 months, 1 year |
| Change of Gartland Classification of X-ray | The change in radiographic resolution as measured by the Gartland Classification scale (1-4) from baseline to 3 months and 1 year. | Baseline, 3 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The change in overall health as measured by the SF-8 | The change in SF-8 from baseline to 3 months and 1 year will be measured. SF-8 is a comprehensive health survey which calculates a score for health in 8 dimensions and as a summed result. | Baseline, 3 months, 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jubin Payandeh, MD | Contact | (807) 344-1123 | payandej@tbh.net | |
| Aaron Burkhart, MD | Contact | 807-767-7677 | aburkhart@nosm.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jubin Payandeh, MD | Thunder Bay Regional Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thunder Bay Regional Health Sciences Centre | Recruiting | Thunder Bay | Ontario | P7B6V4 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D000077555 | Methylprednisolone Acetate |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shockwave therapy | Procedure | A physiotherapist performs the shockwave therapy procedure. Treatment is completed in 4 weekly sessions. Treatment involves applying soundwaves directly to the affected shoulder area using an ultrasound device. |
|
| Depo medrol | Drug | Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression. |
|
|
| Ultrasound device | Device | Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2. |
|
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |